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NCT04829123
The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
Phase 1 trial testing HEC88473 injection in Non-alcoholic Steatohepatitis in 64 participants. Completed in 2 March 2022.
2 March 2022
Quick facts
| Lead sponsor | Dongguan HEC Biopharmaceutical R&D Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 14 May 2021 |
| Primary completion | 2 March 2022 |
| Estimated completion | 2 March 2022 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- HEC88473 injection — full drug profile →
- Placebo
Conditions studied
- Non-alcoholic Steatohepatitis — all drugs for Non-alcoholic Steatohepatitis →
Sponsor
Dongguan HEC Biopharmaceutical R&D Co., Ltd. — full company profile →
Who can join
Adults 18 to 60, any sex, with Non-alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04829123
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HEC88473 injection
Trials testing the same drug.
- NCT05943886 — A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects · Phase 1 · completed
Other recruiting trials for Non-alcoholic Steatohepatitis
Currently open trials in the same condition.
- NCT05945537 — A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH · Phase 1 · recruiting
- NCT05462353 — Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH · Phase 2 · active not recruiting
- NCT05573204 — Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis · Phase 2 · active not recruiting
- NCT04822181 — Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) · Phase 3 · active not recruiting
- NCT04666402 — Integrated Diagnostics for Early Diagnosis of Liver Disease · recruiting
Other Dongguan HEC Biopharmaceutical R&D Co., Ltd. trials
Trials by the same sponsor.
- NCT06148649 — Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus · Phase 2 · completed
- NCT05943886 — A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04829123 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dongguan HEC Biopharmaceutical R&D Co., Ltd.
- Last refreshed: 15 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04829123.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing